KCT0009369招募中Unknown
A 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of SMSP8118 on improvement liver function
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Adult men and women aged 19 to 75 years old at the time of screening test
- •2)A person whose ALT level in the blood test at the time of the screening test exceeds the normal level of the research institute and is within the range of three times the normal upper limit
- •3)A person who agrees in writing to decide voluntarily to participate and comply with the precautions after hearing and fully understanding the detailed explanation of this human application test while meeting selection criteria 1),2)
排除标准
- •1) Those who consume more than 210g of alcohol per week for men and 140g for women on average
- •2) Those whose AST or GGT levels in a blood test at the time of screening exceed 3 times the upper limit of normal at the research institution
- •3) Those who have or have a history of the following diseases:
- •- Patients with acute or chronic hepatitis or carriers of type B or C virus
- •- Those diagnosed or suspected of having severe liver disease such as liver failure, cirrhosis, or liver cancer
- •- Those who have severe liver disease other than fatty liver as a result of liver ultrasound
- •- Those with severe cardiovascular, digestive, endocrine (diabetes, high blood pressure), immune, respiratory, kidney, urinary, neuropsychiatric, musculoskeletal, hematologic, or malignant tumors that require treatment (however participation in the study is possible at the discretion of the primary investigator, taking into account the condition of the research subject.)
- •- Those diagnosed with biliary tract diseases such as jaundice or gallstones (however, Those with asymptomatic gallstones in the gallbladder, etc. may participate in the study at the discretion of the researcher)
- •4) Those who show clinically significant abnormalities in thyroid function test (TSH)
- •5) Those who have taken the following drugs that affect liver function within 4 weeks from the date of the screening test
- •- Antiviral drugs, antibiotics, anti-tuberculosis drugs, infection treatments, anticonvulsants, gout treatments, antidepressants, antifungals, hypoglycemic agents, hyperlipidemia treatments, anesthetics, liver disease treatments, adrenocortical hormones or sex hormones (excluding oral contraceptives) ), NSAIDs, painkillers (acetaminophen), etc.
- •6) Those who have consumed health functional foods, herbal medicine, or over-the-counter medicines for the purpose of improving liver function for more than 7 consecutive days within 4 weeks from the date of screening test
- •7) Persons with a history of hypersensitivity or clinically significant hypersensitivity to ingredients of drugs or human application test products
- •8) People with a history of gastrointestinal disease (e.g. Crohn's disease, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery, etc.) that may affect the absorption of human application test products
- •9) Those who participated in other human application tests within 3 months before the screening test
- •10) Pregnant, lactating, or child-bearing women who do not accept effective contraception during this human application test period
- •11) Those with BMI=30 kg/m2
- •12) Those whose serum creatinine results exceed 2.0 mg/dL in diagnostic medical tests
- •13) A person who is judged by the primary investigator to be physically and mentally unsuitable to participate in a human application test due to the results of a diagnostic medical test or other reasons.
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